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| ID | Type | Description | Link |
|---|---|---|---|
| JDZX2012074 | Other Grant/Funding Number | China national clinical study base project of TCM |
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In order to investigate the time window of acute intracerebral hemorrhage(AICH) by "Blood Activating and Stasis Dispersing" therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the therapy lasts two weeks, and the follow up should last three months. The main indexes are mortality rate, disability rate and the brain hematoma situation. The review is made by the reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.
objective: to investigate the safety and effect of acute cerebral hemorrhage treated with "Blood Activating and Stasis Dispersing" therapy and to verify the traditional methods can influence the brain hematoma enlargement or not.
Methods: from 2013.8 to 2015.12, 360 cases of AICH will be included in 13 research centers. Patients are randomly into 3 groups within 6hrs from onset,such as, group A, blood activating herbal medicine (8 herbals), Group B, herbal medicine without blood activating herbal(6 herbals), Group C, placebo for 10days. All the patients will be treated according AHA guideline of AICH. All patients will be set to the CT at the onset, 24h later and 10-14days after treatment. So the rate of enlargement of brain hematoma in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICH-1 | Experimental | herbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function |
|
| ICH-2 | Active Comparator | herbal medicine without Hirudo, Tabanus,Only 6 herbals |
|
| placebo herbal medicine | Placebo Comparator | Placebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICH-1(herbal medicine with Hirudo, Tabanus) | Drug | 8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma enlargement | 24hrs, 10-14days |
| Measure | Description | Time Frame |
|---|---|---|
| fatality rate | 3 month | |
| modified rankin scale | 3 months | |
| National Institute of Health of stroke scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianwen m Guo, doctor | Guangdong Province Hospital of Tradtional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510120 | China | ||
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31076468 | Derived | Zeng L, Tang G, Wang J, Zhong J, Xia Z, Li J, Chen G, Zhang Y, Luo S, Huang G, Zhao Q, Wan Y, Chen C, Zhu K, Qiao H, Wang J, Huang T, Liu X, Zhang Q, Lin R, Li H, Gong B, Chen X, Zhou Y, Wen Z, Guo J. Safety and efficacy of herbal medicine for acute intracerebral hemorrhage (CRRICH): a multicentre randomised controlled trial. BMJ Open. 2019 May 9;9(5):e024932. doi: 10.1136/bmjopen-2018-024932. | |
| 27652041 |
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The study has recruited 278 subjects by so far
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|
| placebo | Drug | placebo herbal medicine, one dose,bid, for 10 days |
|
|
| ICH-2(herbal medicine without Hirudo, Tabanus) | Drug | (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days |
|
|
| 10-14days, 90days |
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| Guangzhou Hospital of Integrated traditional and west medicine | Guangzhou | Guangdong | 510800 | China |
| Panyu Hospital of Chinese Medicine | Guangzhou | Guangdong | 511400 | China |
| Boluo County People's Hospital | Huizhou | Guangdong | 514610 | China |
| Jiangmen Wuyi Traditional Chinese Medicine Hospital | Jiangmen | Guangdong | 529000 | China |
| The hospital of Chinese Medicine of Conghua City | Jiekou | Guangdong | 5109000 | China |
| Lianjiang People's hospital | Lianjiang | Guangdong | 524400 | China |
| Zengcheng City Hospital of traditional Chinese Medicine | Licheng | Guangdong | 510000 | China |
| Boji-affiliated Hospital of Sun Yat-sen University | Licheng | Guangdong | 511300 | China |
| Yangjiang Hospital of Traditional Chinese Medicine | Yangjiang | Guangdong | 529500 | China |
| 1st people's hospital of Yueyang city | Yueyang | Hunan | 414000 | China |
| Shenyang No.2 traditional Chinese medical hospital | Shenyang | Liaoning | 110000 | China |
| Liaocheng City People's Hospital | Liaocheng | Shandong | 252000 | China |
| Shouguang City People's Hospital | Shouguang | Shandong | 262700 | China |
| Derived |
| Zeng L, Guo J, Wang J, Zhang Q, Li H, Lin R. Clinical re-evaluation of removing blood stasis therapy in treating acute intracerebral hemorrhage safety and efficacy: a protocol for a randomized, controlled, multicenter study (CRRICH Trial). Springerplus. 2016 Sep 1;5(1):1466. doi: 10.1186/s40064-016-3136-y. eCollection 2016. |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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